Increased fees coming into effect on 1 April 2011
News
Fees payable to the European Medicines Agency by applicants and marketing-authorisation holders are increasing by 2.1% on Friday 1 April.
Full details of the new fees levels are available in the Commission Regulation (EU) No 301/2011 of 28 March 2011 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate, its Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures and the corresponding Explanatory note on fees payable to the European Medicines Agency, published today. These documents include the new fees for all types of procedure handled by the Agency for human and veterinary medicines, including marketing-authorisation applications, post-authorisation procedures, scientific advice and inspections.
Every year, the Agency adjusts its fees on 1 April, in line with the European Union (EU) inflation rate for the previous year. The current increase reflects the inflation rate for 2010, as published in the Official Journal of the European Union.
All applications received at the Agency by Thursday 31 March will be charged at the current fee and reduction rates. Applications received after that date will be charged the adjusted fees. For scientific advice and protocol assistance for human medicines, the cut-off point will be the date of validation of the request for advice.